Shoulder Pain and Function in Individuals With Implantable Cardiac Electronic Devices

NCT07349914 | Enrolling By Invitation

• 1 other identifier: FTREK25/129
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of our study is to evaluate shoulder pain, range of motion, postural changes, muscle tightness, activities of daily living, upper extremity functional status, and exercise capacity in individuals with Implantable Cardiac Electronic Devices (ICED), during each follow-up visit over a two-year period, and to compare the assessment outcomes according to different types of implantable cardiac electronic devices. The secondary aim of our study is to investigate the factors determining the severity and duration of shoulder pain in these patients.

Conditions

Pain; Upper Extremity; Posture; Function; Daily Activities; Implantable Cardiac Electronic Devices

Outcome Measures

Primary Outcomes (4)

• Shoulder Pain and Disability

  The Shoulder Pain and Disability Index (SPADI) will be used for assessment. The pain subscale comprises 5 items, and participants are asked to rate their pain over the past week during various movements using a Visual Analog Scale between 0 to 10 points. The disability subscale includes 8 items, assessing the level of difficulty experienced during different activities over the past week, also rated on a VAS from 0 (no difficulty) to 10 (unable to perform). Higher scores indicate greater pain and functional limitation. When the entire questionnaire is evaluated, a total score of 0 represents maximum well-being, whereas 130 represents the worst possible condition.

  Follow-up over 2 years, with assessments every 6 months

• Assessment of Shoulder Range of Motion

  A universal goniometer will be used to assess the range of motion of the shoulder. Active shoulder flexion, abduction, internal rotation, and external rotation will be measured in accordance with standard assessment principles. Each movement will be measured three times, and the average value will be recorded in degrees.

  Follow-up over 2 years, with assessments every 6 months

• Assessment of Upper Extremity Functional Exercise Capacity

  Unsupported Upper Limb Exercise Test (UULEX):Participants will be seated on a chair with their knees touching the wall where the UULEX lines are displayed. The UULEX consists of 8 horizontal levels, each 84 cm in width and 8 cm in height, with 15 cm between the centers of each level. The lowest line corresponds to the participant's knee level. Participants hold a plastic bar weighing 0.2 kg at shoulder width and move it from the hips toward the different levels of the UULEX lines. Each movement starts and ends at the hip joint. The first level is performed for 2 min, and each subsequent level is performed for 1 min. Using a metronome, participants lift the bar 30 times per min. Once participants reach their max height, the 0.2 kg bar is replaced with a 0.5 kg bar, and participants continue lifting to max height. Subsequently, the weight is increased by 0.5 kg per min at the specified level, up to max of 2 kg. Participants are instructed to continue the test until symptom limitation.

  Follow-up over 2 years, with assessments every 6 months

• Tightness of muscle

  Pectoralis minor and pectoralis major muscle tightness tests will be performed during musculoskeletal examination using a tape.

  Follow-up over 2 years, with assessments every 6 months

Secondary Outcomes (5)

• Posture

  Follow-up over 2 years, with assessments every 6 months

• Assessment of Musculoskeletal Pain

  Follow-up over 2 years, with assessments every 6 months

• Assessment of Upper Extremity Functional Status

  Follow-up over 2 years, with assessments every 6 months

• Assessment of Activities of Daily Living

  Follow-up over 2 years, with assessments every 6 months

• Assessment of Body Awareness

  Follow-up over 2 years, with assessments every 6 months

Study Arms (1)

Individuals with implantable cardiac electronic devices

Those who have recently undergone implantable cardiac electronic devices implantation Those scheduled for implantable cardiac electronic devices implantation Individuals with implantable cardiac electronic devices

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

Not applicable- observational study

Individuals with implantable cardiac electronic devices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include adults aged 18 years and older who have an implantable cardiac electronic device, including pacemakers, cardiac resynchronization therapy devices (CRT-P or CRT-D), or implantable cardioverter defibrillators (ICD).

You may qualify if:

• Aged 18 years or older,
• Having an implantable cardiac electronic device
• Meeting the clinical indication for CIED implantation
• Without any complications at the most recent follow-up,
• Clinically stable for at least the past month, with any comorbid chronic conditions (e.g., hypertension, diabetes) well-controlled, considered suitable for assessment, and willing to provide informed consent to participate in the study.

You may not qualify if:

• Individuals with neurological, orthopedic, or psychiatric disorders,
• Individuals with a history of shoulder surgery or shoulder injury,
• Individuals with cognitive or mental impairments preventing comprehension of the study procedures, or those unwilling to participate.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Samanpazari, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD, Assoc. Prof.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: January 20, 2026
• Study Start: February 14, 2025
• Primary Completion (Estimated): July 14, 2027
• Study Completion (Estimated): August 14, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

TU (1)